| CTRI Number |
CTRI/2021/03/032090 [Registered on: 17/03/2021] Trial Registered Prospectively |
| Last Modified On: |
13/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study for Comparison between Tramadol and dexmedetomidine for treatment of post-spinal anaesthesia shivering |
|
Scientific Title of Study
|
Randomised double-blind comparative study of dexmedetomidine and tramadol for post-spinal anaesthesia shivering |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr parth hirpara |
| Designation |
Anaesthesia resident |
| Affiliation |
DR D Y PATIL MEDICAL COLLEGE NAVI MUMBAI |
| Address |
Room no. 306 Dr D.Y.patil medical college hostel sector -5 , Navi mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
7874213149 |
| Fax |
|
| Email |
parth9087@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr varsha vyas |
| Designation |
proffesor in anaesthesia |
| Affiliation |
DR D Y PATIL MEDICAL COLLEGE NAVI MUMBAI |
| Address |
Anaesthesia department- Dr D.Y.patil medical college sector -5 , Navi mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9819583232 |
| Fax |
|
| Email |
varsha.vyas011@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr varsha vyas |
| Designation |
proffesor in anaesthesia |
| Affiliation |
DR D Y PATIL MEDICAL COLLEGE NAVI MUMBAI |
| Address |
Anaesthesia department- Dr D.Y.patil medical college sector -5 , Navi mumbai
Thane
MAHARASHTRA
400706
India |
| Phone |
9819583232 |
| Fax |
|
| Email |
varsha.vyas011@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr D.Y.Patil Hospitl , Nerul sector-9 ,Navi Mumbai 400706 |
|
|
Primary Sponsor
|
| Name |
Dr DYPatil Hospital |
| Address |
Nerul Sector 9 , Navi Mumbai 400706 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR PARTH |
Dr D.Y.Patil Hospital |
Operation theater complex in anesthesia department.
Thane
MAHARASHTRA |
7874213149
parth9087@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IECBH DYPSOM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 7||Osteopathic, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
dexmedetomidine 0.5 mcg/kg
tramadol 0.5mg /kg |
patient developing shivering after spinal anaesthesia intervened randomly by Dexmedetomidine -0.5 mcg/kg or Tramadol- 0.5 mg/kg , slow single intravenous bolus .anyone of two drugs will be used in one patient according to randomization table in single arm. |
| Comparator Agent |
dexmedetomidine and tramadol for post-spinal anaesthesia shivering |
Dexmedetomidine -0.5 mcg/kg OR Tramadol- 0.5 mg/kg , slow single intravenous bolus to the patient according to computer generated randomization table ,anyone of two drugs will be used in one patient according to randomization table in single arm. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
>Patient giving consent
>patients of either gender aged 18-65 years scheduled for elective lower abdominal, lower limb surgeries under spinal anaesthesia
>American Society of Anesthesiologist physical status class I and II
|
|
| ExclusionCriteria |
| Details |
• Patients with known hypersensitivity to dexmedetomidine or tramadol, cardio-pulmonary, renal or hepatic disease, hyperthyroidism, psychiatric disorder, urinary tract infection, severe diabetes or autonomic neuropathies, known history of substance or alcohol abuse, patients receiving any pre-medication.
• cesarean section
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| cessation of shivering , Episodes of recurrence |
shivering ceasing within 15 min after treatment , time of recurrence after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse effects such as nausea, vomiting, bradycardia (50/min), hypotension (20% of baseline), dizziness; and sedation score will be noted. The degree of sedation will be graded on a four-point scale as Grade 1: Awake and alert, Grade 2: Drowsy, responsive to verbal stimuli, Grade 3: Drowsy, arousable to physical stimuli, Grade 4: Unarousable |
every 15 min interval hemodynemic changes |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/04/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To compare efficacy of dexmedetomidine versus tramadol for control of post-spinal anaesthesia shivering.
To compare the perioperative variations in hemodynamic parameters and the incidence of adverse effects among the groups.
Dexmedetomidine (α2 adrenergic agonist) has been used for
prevention of post anaesthesia shivering. Its use for the treatment of
post-spinal anaesthesia shivering has not been evaluated. The aim of
this study is to evaluate and compare the efficacy, haemodynamic and
adverse effects of dexmedetomidine with those of tramadol, when used for
control of post-spinal anaesthesia shivering.
|